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Actinium Pharmaceuticals Launches Innovative Clinical Trial Program

Actinium Pharmaceuticals, Inc., a leading company in targeted radiotherapy development, recently announced a new clinical trial program aimed at evaluating the effectiveness of its investigational drug, Actimab-A, in combination with two prominent PD-1 checkpoint inhibitors, KEYTRUDA® and OPDIVO®. These inhibitors have previously been approved for various solid tumor treatments but have faced limitations in efficacy due to the influence of specific immune cells known as Myeloid Derived Suppressor Cells (MDSCs).

Understanding the Challenge

MDSCs play a dual role in the tumor microenvironment by both promoting tumor growth and suppressing the body's immune response. Specifically, they hinder the activity of T-cells, which are critical for the immune system to recognize and combat cancerous cells. Historically, the presence of MDSCs has been associated with worse clinical outcomes in patients receiving PD-1 therapies.

Recognizing the need for a new approach, Actinium's clinical trials aim to investigate whether Actimab-A can effectively reduce MDSC levels by targeting the CD33 antigen they express. This reduction is hypothesized to enhance the effectiveness of PD-1 inhibitors, potentially revolutionizing treatment options for patients with solid tumors.

The Clinical Trial Design

The trial program will consist of several controlled, head-to-head studies comparing the efficacy of Actimab-A in combination with either KEYTRUDA® or OPDIVO® against the use of each PD-1 inhibitor alone. The initial focus will be on two specific types of cancers: Head and Neck Squamous Cell Carcinoma (HNSCC) and Non-Small Cell Lung Cancer (NSCLC). Adult patients with proven PD-L1 expression who have advanced forms of these cancers will be randomized into different treatment groups to assess the effectiveness and safety of the combination therapies.

Key endpoints of the trials will include Overall Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS). Furthermore, researchers will collect biomarker data to monitor changes in MDSC populations and T-cell activity in the patients’ blood, aiming to draw a direct correlation between these factors and clinical outcomes.

Actinium's Commitment to Innovation

Dr. Avinash Desai, Chief Medical Officer of Actinium, expressed optimism about the new trial program, emphasizing the novel approach to dealing with MDSCs and the potential to significantly improve therapy responses for patients who have limited options. Similarly, Sandesh Seth, Chairman and CEO, highlighted the importance of the trials in addressing a growing market that could encompass over 500,000 patients facing solid tumors. The company's pioneering efforts in combining Actimab-A with PD-1 inhibitors could pave the way for new treatment modalities that might shift current paradigms in cancer therapy.

Looking Ahead

Actinium Pharmaceuticals expects to release initial proof-of-concept data from these trials in the latter half of 2025. Given the immense potential for Actimab-A as a cornerstone therapy in the treatment of solid tumors, these groundbreaking trials may unlock new hope for patients battling with cancer, potentially leading the way for new standards in therapeutic care.

As the landscape of cancer treatment continuously evolves, Actinium's dedication to innovative treatments harnessing targeted radiotherapies positions the company at the forefront of a promising medical frontier. With solid clinical data anticipated in the near future, the healthcare community watches closely as Actinium embarks on this next chapter of clinical exploration.